Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-03-08 @ 5:06 AM
Study NCT ID:
NCT00002027
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003457', 'term': 'Cryptosporidiosis'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D017088', 'term': 'AIDS-Related Opportunistic Infections'}, {'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D007411', 'term': 'Intestinal Diseases, Parasitic'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011529', 'term': 'Protozoan Infections, Animal'}, {'id': 'D010273', 'term': 'Parasitic Diseases, Animal'}, {'id': 'D003048', 'term': 'Coccidiosis'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000820', 'term': 'Animal Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009894', 'term': 'Opportunistic Infections'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C057884', 'term': 'diclazuril'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1990-06', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['AIDS-Related Opportunistic Infections', 'Cryptosporidiosis', 'Diarrhea', 'diclazuril', 'Coccidiostats', 'Acquired Immunodeficiency Syndrome'], 'conditions': ['Cryptosporidiosis', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '2397069', 'type': 'BACKGROUND', 'citation': 'Connolly GM, Youle M, Gazzard BG. Diclazuril in the treatment of severe cryptosporidial diarrhoea in AIDS patients. AIDS. 1990 Jul;4(7):700-1. doi: 10.1097/00002030-199007000-00020. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Soave R, Dieterich D, Kotler D, Gassyuk E, Tierney AR, Liebes L, Legendre R. Oral diclazuril therapy for cryptosporidiosis. Int Conf AIDS. 1990 Jun 20-23;6(1):252 (abstract no ThB520)'}]}, 'descriptionModule': {'briefSummary': "To evaluate the safety and efficacy of diclazuril capsules compared with placebo capsules as treatment of cryptosporidial related diarrhea in AIDS patients. Treatment efficacy will be based on the drug's clinical results and on its anti-protozoan effects. Safety will be assessed by the occurrence of side effects as reported by patients at their visits and by frequent monitoring of hematology, biochemistries, and urinalysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Patients who require anti-diarrheal medication must have received only one anti-diarrheal medication, loperamide, for at least 7 days prior to study entry. Dose of loperamide cannot be increased during study.\n* Aerosolized pentamidine.\n* Ganciclovir for cytomegalovirus (CMV) retinitis only but patient must be stable at least 4 weeks prior to study entry.\n* Zidovudine (AZT).\n* Nystatin for oropharyngeal infections if not taken within 2 hours of diclazuril.\n\nPatients must have:\n\n* Diagnosis of AIDS that is confirmed HIV positive by Western blot or AIDS defined diagnosis, or CDC defined AIDS. Stool specimens positive for cryptosporidium oocysts.\n* Given written informed consent after the purpose and nature of the study, as well the possible drug-related adverse effects, have been explained.\n* Ability to return for all subsequent applicable visits on days 8, 15, 21, and, if necessary, 28.\n\nPrior Medication:\n\nAllowed:\n\n* Aerosolized pentamidine.\n* Loperamide.\n* Ganciclovir for cytomegalovirus (CMV) retinitis.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Diagnosis of cryptosporidiosis less than 4 weeks prior to study entry, unless patient has been diagnosed with AIDS for more than 4 weeks.\n* Other treatable enteric pathogens including Clostridia must be treated and eradicated prior to study entry.\n* Inability to swallow capsules.\n* Uncontrolled vomiting.\n\nConcurrent Medication:\n\nExcluded:\n\n* Trimethoprim/sulfamethoxazole (Bactrim).\n* Ganciclovir for any other reason except cytomegalovirus (CMV) retinitis.\n* Other antibiotics.\n* Other anti-protozoal drugs.\n* Anti-fungal drugs other than nystatin.\n* Amphotericin B.\n* Other investigational drugs.\n\nPatients with the following are excluded:\n\n* Diagnosis of cryptosporidiosis less than 4 weeks prior to study entry, unless patient has been diagnosed with AIDS for more than 4 weeks.\n* Inability to swallow capsules.\n* Uncontrolled vomiting.\n* Life expectancy of \\< 28 days.\n* Can not be depended upon to follow the instructions of the investigator.\n* Participation in an investigational study within 15 days of study entry.\n\nPrior Medication:\n\nExcluded within 15 days of study entry:\n\n* Another investigational drug or device (except aerosolized pentamidine).\n\nPrior Treatment:\n\nExcluded within 15 days of study entry:\n\n* Participation in an investigational study.'}, 'identificationModule': {'nctId': 'NCT00002027', 'briefTitle': 'Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)', 'orgStudyIdInfo': {'id': '038A'}, 'secondaryIdInfos': [{'id': 'JRD 64,433/1101'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Diclazuril', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Dr Douglas Dieterich', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Cornell Univ Med Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10025', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Saint Luke's - Roosevelt Hosp Ctr", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen, LP', 'class': 'INDUSTRY'}}}}